MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.5MM DRILL BIT W/6MM STOP 13MM F/90 SCRWDRVR MTRXMANDBL; DRILL, BONE, POWERED

Catalog Number 03.505.075

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent the osteoplasty surgery for lower jaw deformity.During the drill, the drill bit broke.The surgery was completed successfully.The fragment was not removed.The patient was stable.This complaint involves one (1) device.This report is for (1) 1.5mm drill bit w/6mm stop, 13mm f/90° screwdriver matrixmandible.This is report 1 of 1 (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation selection investigation site: cq zuchwil selected flow: damaged.Visual inspection: the received drill bit shows that that approx.4mm from the fluted tip section is broken off.The broken off portion was not returned for investigation.The shaft and connection at the end are otherwise still in good condition.Dimensional inspection: because of the damages, and since the broken off portion was not returned, the complaint relevant dimensions cannot be checked to print specifications anymore.Drawing/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.The used material was stainless steel 1.4112 per iso 7153-1 as required and the measured harness was within the specification of 600 0/+55 hv.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.Based on the provided information we are not able to determine the exact cause of this complaint.We only can assume that a mechanical overloading situation or lateral stress has caused the breakage of the delicate 1.5 mm drill bit.Please also note; blunt drill bits require more mechanical power during the application, therefore we would like to draw your attention on page 4 in the leaflet ¿important information¿ : check instruments for sound surfaces, and correct adjustment and function.Do not use severely damaged instruments, instruments with unrecognizable markings, corrosion, or blunt cutting surfaces.We conclude that the cause of failure is not due to any manufacturing non-conformances.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot part number: 03.505.075, synthes lot number: f-19451, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: april 08, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.5MM DRILL BIT W/6MM STOP 13MM F/90 SCRWDRVR MTRXMANDBL
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10550439
• MDR Text Key: 207574128
• Report Number: 8030965-2020-07175
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 07611819353589
• UDI-Public: (01)07611819353589
• Combination Product (y/n): N
• PMA/PMN Number: K082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.075
• Device Lot Number: F-19451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR